Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)
Part of paid clinical trials in Winston-Salem, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT05800145
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Resource information Supplemental Nutrition Assistance Program (SNAP) — BEHAVIORALParticipants randomized to the resource referral arm will receive a tailored list of information about community resources. The list will include information about local emergency food resources (e.g. local food pantries) and government programs to address FI (e.g. SNAP).
- community health worker (CHW) — BEHAVIORALParticipants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.
- medically tailored meals — BEHAVIORALParticipants will receive 10 medically tailored meals delivery to their home weekly for 3 months
Study Details
In the US, 47% of adults have hypertension (HTN), and HTN accounts for more cardiovascular disease (CVD) deaths than any other CVD risk factor. Thus, the lack of an adaptive, stepped-care intervention to address FI in patients with HTN is a critical problem affecting a large, vulnerable population.
Key Dates
- Start date
- May 16, 2023
- Status verified
- Sep 2024
- Primary completion
- Sep 3, 2024
- Completion
- Sep 3, 2024
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: resource referralwill receive a tailored list of information about community resources. The list will include information about local emergency food resources (e.g. local food pantries) and government programs to address Food Insecurities (FI) Supplemental Nutrition Assistance Program (SNAP).
- Active Comparator: community health worker (CHW) interventionassist participants in addressing FI and supporting them in their blood pressure management
- Active Comparator: medically tailored meals (MTM)Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months
Primary Outcome Measure
Systolic Blood Pressure Readings [ Time Frame: Baseline ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | - |
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